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IRB Exemption

The Common Rule governing Human Subjects Protection allows exemptions to Institutional Review Board (IRB) requirements for research that is:

“designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.” (45 CFR 46.104)

The regulation further requires that:

“Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or as the department or agency head may determine, a list of their research and demonstration projects conducted or supported under this provision. The project must be published on this list prior to commencing the research involving human subjects.”

This web page provides ASPE’s list of research projects supported under this provision of the Common Rule.


Study Title: Developing a Database of Substance Use Disorder Treatment Needs

Abstract: The gap between those who need substance use disorder treatment and those who receive it remains large, and efforts to build treatment capacity are hindered by a lack of information regarding the types of treatment that are needed. Several states collect this type of information, but it has not been used systematically to provide information about system capacity. This project will work with a selection of states that have more complete patient treatment assessments to create a database that links this information to utilization data or Medicaid claims data. This multi-state database could be used to help understand the distribution of treatment needs, and how that need compares to treatment availability and utilization, thus identifying areas where resources could be invested to minimize the treatment gap. This data could also be used to support efforts to plan workforce and treatment capacity needs.

Contractor (or Intramural): RTI International

Period of Performance: September 2021 to September 2023


Study Title: Opportunities for Interventions: Medicare Advantage Enrollment Among Older Adults in HUD-Assisted Housing

Abstract: Previous work by ASPE and the Department of Housing and Urban Development (HUD) shows that Medicare beneficiaries in HUD-assisted housing have more chronic conditions than beneficiaries not receiving housing assistance. HUD and HHS have been examining models of potential care coordination interventions that could be based in HUD-assisted housing, such as the Support And Services at Home (SASH) model in Vermont and HUD’s iWISH demonstration. One potential barrier to scaling such models is that within a given building or neighborhood, HUD residents may be served by different managed care organizations. As Medicare Advantage (MA) participation increases, MA plans may have a reason to consider focusing on participants in HUD-assisted housing. While individual MA plans may not have enough beneficiaries within particular developments to justify an onsite intervention, multiple plans could pool resources if they were aware of the opportunity to reach large numbers of enrollees. Project findings could serve as a foundation for future care coordination between multiple MA plans. This project will link HUD administrative data on public and assisted housing programs with MA plan enrollment data to identify current geographic concentrations of MA beneficiaries in public and assisted housing, and determine if clusters of plans exist. No cell size less than 10 individuals will be reported, and no personally identifying information will be available. Data security and privacy requirements, as required by CMS and HUD, will be followed.

Contractor (or Intramural): The Lewin Group

Period of Performance: September 2020 to January 2023


Study Title: Virtual Human Service Delivery under COVID-19: Scan of Implementation and Lessons Learned

Abstract: This project will entail a scan of human services programs to help ASPE understand preliminary lessons learned about delivering human services virtually—via videoconferencing, telephone, text, email, instant messaging, web, etc. (i.e. not in-person). ASPE hopes to identify lessons from the extensive transition to virtual services in Spring and Summer 2020 due to the COVID-19 pandemic. The study will explore a range of programs, services, and circumstances where human services have been offered largely virtually for the first time in response to the pandemic. We aim to understand how the services are provided, and to identify successes, challenges, and lessons from this shift in service approach. State and local administrators, program managers, frontline workers, and a sample of program participants will be interviewed in study sites to understand their perspectives on this change in service delivery approach. We are particularly interested in perceptions and outcomes related to effectiveness—where there is evidence that services are delivered less well, as well, or better than in-person.

Contractor (or Intramural): Mathematica

Period of Performance: July 2020 to December 2020


Study Title: Freeing Children for Adoption: States’ Use of Exceptions to Federal Requirements on Termination of Parental Rights for Children in Foster Care for Extended Periods

Abstract: This project will examine the extent to which terminations of parental rights (TPR) are conducted for children who have spent at least 15 of the previous 22 months in foster care, freeing them for adoption. This timeline, with certain permissible exceptions, has been part of federal child welfare law since 1997, though recent monitoring results show that few states adhere to the requirement. Under the current phase of the research, a contractor will conduct case studies of several states to explore these states' policies and practices with respect to granting exceptions. State officials, caseworkers, judges, and potentially birth and foster families will be interviewed in study states to gain a perspective on which statutory exceptions are used, the rationales and practices regarding the granting of exceptions, and agencies' and courts' perspectives on the TPR requirement and the value and purpose of exceptions.

Contractor (or Intramural): Mathematica

Period of Performance: September 2019 to August 2020


Study Title: A Model Effective Marginal Tax Rate Calculator for Families and Caseworkers

Abstract: When families increase earnings, they may also experience a change in program benefits and taxes, and the amount of new earnings not retained (on net) is the family’s marginal tax rate. On the road to self-sufficiency, families need to know their own effective marginal tax rate: as families make strides to increase earnings, they need to know which benefits would be reduced, by how much, and when. Yet this vital information is frequently elusive to even caseworkers who advise families on how to use work to achieve self-sufficiency. To address the problem, this contract aims to develop an accurate and comprehensive model marginal tax rate (MTR) calculator for use by both caseworkers and families. The model MTR calculator will accurately reflect program rules applicable at the state and local level, and be comprehensive by including every major program available to families in a particular state or county.

The proposed calculator would address outsized fears of benefit loss that may hold some families back from securing additional earnings. At a basic level, knowledge of how and when benefits change is important for financial planning and reallocating resources for necessities such as food and rent. Without information about benefit reductions, struggling families may guess or even fail to anticipate benefit reductions at all. Unanticipated benefit reductions can deal an emotional blow to families working hard to get ahead. With this accurate and comprehensive calculator, caseworkers would be prepared to help families plan for independence. Results are also likely to be of interest to policymakers who are interested in incentivizing work.

The successful development of a model MTR calculator would serve as a proof of concept for an interactive calculator that other federal, state, and local efforts could follow. The model would be accompanied by a toolkit that would provide the open source code for the web application and lessons learned in working with state/local partners to develop the calculator so that it can be easily replicated by other localities.

Contractor (or Intramural): Manhattan Strategy Group

Period of Performance: September 2019 to June 2021